Simultaneous Determination of Ceftriaxone Sodium and Statin Drugs in Pharmaceutical Formulations and Human Serum by Rp-HPLC

Abstract

An accurate, sensitive and least time consuming reverse phase high performance liquid chromatographic (RP-HPLC) method for the estimation of ceftriaxone in the presence of statin drugs in formulation and human serum has been developed and validated. Chromatographic separation was conducted on prepacked Purospher Star, C18 (5 mm, 250 x 4.6 mm) column at room temperature using methanol:water:acetonitrile (70:15:20 v/v/v) as a mobile phase, pH adjusted at 2.8 with ortho-phosphoric acid and at a flow rate of 1.0 mL/minute, while UV detection was performed at 240 nm. The results obtained showed a good agreement with the declared content. The method shows good linearity in the range of 2.5-25 µg/mL with a correlation coefficient 0.9966 -0.9998 (inter-and intra-day RSD < 2 %).The limit of detection and quantification for ceftriaxone and statins in pharmaceutical formulation and serum were in the range 0.124 -1.006 µg/mL. Analytical recovery was >98.72 %. The proposed method may be used for the quantitative analysis of commonly administered statin's i.e. simvastatin, rosuvastatin atorvastatin and pravastatin alone or in combination with ceftriaxone from raw materials, dosage formulations and in serum. The established HPLC method is rapid, accurate and selective, because of its sensitivity and reproducibility.

A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

“…The LOQ value for lovastatin was relatively high, 400 ng/mL. Another even less sensitive LC/DAD method for quantification of several HMGCoA reductase inhibitors in human plasma was developed by Sultana and co-workers [92].…”

“…Despite the fact that these drugs seem to be structurally similar, development of the method for their simultaneous determination in complex biological samples is quite challenging task as they differ significantly in terms of solubility, polarity, stability as well as optic characteristics. Until now several analytical methods have been developed for the determination of statins in biological samples simultaneously, simvastatin and atorvastatin [83], rosuvastatin and atorvastatin [90], simvastatin, pravastatin, rosuvastatin and atorvastatin [92].…”

“…Therefore, these methods could be useful in daily routine sample handling, when many samples from patients taking different drugs together with HMG-CoA reductase inhibitors are analyzed in clinical laboratories. Recently, several chromatographic methods have been developed for the quantification of statin drugs in combination with other drugs, most of them are commonly used in treatment of cardiovascular disease: atenolol, spironolactone, glibenclamide [61], metoprolol succinate [72], valsartan and chlorthalidone [76,87], timolol maleate, diclofenac sodium [81], fenofibric acid [85], ezetimibe [91], ceftriaxone [92], acetylsalicylic acid [94], amlodipine [98] and losartan, atenolol, acetylsalicylic acid [99].…”

New Method for Optimization and Simultaneous Determination of Sparfloxacin and Non Steroidal Anti-Inflammatory Drugs: Its &lt;i&gt;In-Vitro&lt;/i&gt; Application

“…Nemutlue et al [13] published simultaneous separation and determination of seven quinolones using HPLC and analysis of levofloxacin. Sultana et al [14][15][16] provided simultaneous determination of NSAIDs with diltiazem and ceftrioxazone sodium. Koichi Suenami et al [17] developed more sophisticated and sensitive analytical method for the simultaneous determination of NSAID's in human plasma using Oasis HLB solid-phase extraction, followed by reversed-phase high-performance liquid chromatography and quadruple mass spectrometry with electrospray ionization operated in the negative ion mode.…”

An Ultra-Sensitive and Selective LC-UV Method for the Simultaneous Determination of Pravastatin, Diltiazem, Naproxen Sodium and Meloxicam in API, Pharmaceutical Formulations and Human Serum

“…For the determination of MEL, spectrophotometric [25], Voltammetric [26], fluorimetric [27], electrochemical [28], HPLC [29] and capillary electrophoresis [30] are reported. A number of methods for individual or simultaneous determination of these and many other [31][32][33] drugs have also been developed by our research group like liquid chromatographic method for simultaneous determination of ceftriaxone sodium [34] with statin, lisinopril with statin [35] and NSAIDs [36], NSAID with statin [37,38], DTZ with non steroidal anti-inflammatory drugs [39], MEL [40], , NAP [41].…”